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Brief Title: A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in Participants Aged 1 to 65 Years of Age With Tuberous Sclerosis Complex
Official Title: A Phase 4, Interventional, Multicenter, Open-Label, Single-Arm Study to Assess Behavioral and Other Co-occurring Outcomes Following Treatment With EPID(I/Y)OLEX as Add-on Therapy in Participants (Aged 1 to 65 Years Old) With Seizures Associated With Tuberous Sclerosis Complex
Study ID: NCT05864846
Brief Summary: The purpose of this study is to investigate behavioral and other co-occurring outcomes with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis complex (TSC) who experience seizures.
Detailed Description:
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of California, Los Angeles (UCLA), Los Angeles, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Nicklaus Children's Health, Miami, Miami, Florida, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Minnesota Epilepsy Group, Roseville, Minnesota, United States
Duke University Hospital, Durham, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Le Bonheur Children's Hospital, Memphis, Tennessee, United States
University of Texas Health Science Center at Houston - Clinical Research Unit, Houston, Texas, United States
University of Texas Health Science Center - San Antonio, San Antonio, Texas, United States
University of Virginia, Charlottesville, Charlottesville, Virginia, United States
The Children's Memorial Health Institute, Warszawa, , Poland
University Hospitals Bristol NHS Foundation Trust, Bristol, , United Kingdom
Sheffield Children's NHS Foundation Trust, Sheffield, , United Kingdom